Job Description
Hello,
Hope are you doing well.
Role: Quality Control Technician
Location: Scarborough, Maine
Duration: 05 Months on W2
Responsibilities:
Conduct product testing, including testing to support complaint investigations and stability verification
Generate product testing results reports
Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.
Conduct spot-check inspections/audits of production operations
Participate in the internal audit program
Write, review and approve Standard Operating Procedures (SOPs) as necessary
May assist in supporting the Document Control program, record retention areas, and sample retention areas
May support returned instrument processing
Log returned instruments from the field.
Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.
Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.
As necessary, process instrument documentation for return to repair facility, and pack instruments as required.
Experience:
Bachelor's degree in a scientific or technical area or equivalent combination of experience and education. At least one year in quality assurance role in medical device industry is preferred.
Other Skills and Abilities:
Ability to follow procedures and accurately document results.
Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures.
Attention to detail.
Ability to use bleach for cleaning purposes is required.